The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Titan Ti Suture Anchor System, Models 22-9055, 22-9055n, 22-9065, 22-9065n, 22-9022, 22-9005,, 22-9006.
| Device ID | K101184 |
| 510k Number | K101184 |
| Device Name: | TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Contact | Valerie Defiesta-ng |
| Correspondent | Valerie Defiesta-ng ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-28 |
| Decision Date | 2010-05-18 |
| Summary: | summary |